12 results
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25ms
·
Sources: EU EUDAMED, US FDA
CALMPS: BONE, MASTIN, LEWIN, BRAND
FDA 510(k)
FDA Class 1
·Orthopedic
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591011031·Neoprene Hinged Knee Wrap, X-Large
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300281·Mand. 1. Molar band W-Fit right 28
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300280051·Mand. 1. Molar band W-Fit right 28
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300280501·Mand. 1. Molar band W-Fit right 28
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300280101·Mand. 1. Molar band W-Fit right 28
CPC BY SORING GMBH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESURFX 1565NM LASER MODULE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·November 19, 2010
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·January 25, 2013
EX-PRESS MINI GLAUCOMA SHUNT
FDA Adverse Event
Malfunction
·OPTONOL, LTD·Product code KYF·March 10, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024